Ambulatory infusion pumps recalled due to erroneous software installation
InfuTronix is recalling Nimbus PainPro ambulatory infusion pumps after an unreleased software version was installed in error. The defective units may impact patient safety.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: No illnesses or injuries reported; however, per FDA severity criteria, this Class II recall of a high-risk device (infusion pump) with software error constitutes a risk-of-harm situation classified as High (score 3).
Plain-English summary
InfuTronix LLC is recalling Nimbus PainPro Ambulatory Infusion Pumps (Model IT1072), sold as kits IT1075-DUKE-HSP, IT1076-DUKE-HSP, and IT1077-DUKE-HSP. An unreleased Version 4 Protocol Library was installed on these devices in error. These devices may impact patient safety if used on patients.
The recall affects 74 units distributed nationwide in North Carolina and Ohio. Affected devices are identified by Lot number 2009231440 and specific serial numbers ranging from 807483 to 807658. The FDA has classified this recall as Class II.
For questions or to report issues with this device, contact the FDA or InfuTronix LLC directly.
The recalled product
- Product
- Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP
- Manufacturer
- InfuTronix LLC
- Category
- Medical Device — Infusion Pump
- Affected units
- 74
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- (UDI): (01)00817170020086
- Lot: 2009231440
- Serial Numbers: 807483
- 807484
- 807485
- 807486
- 807487
- 807489
- 807490
- 807491
- 807492
- 807493
- 807494
- 807495
- 807496
- 807497
- 807498
- 807499
- 807500
- 807502
Distribution
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